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Date: Wednesday, May 7, 1997
FOR IMMEDIATE RELEASE
Contact: Food and Drug Administration, Sharon Snider: 301­443­3285, 
Broadcast Media: 301­827­3434, Consumer Hotline:  800­532­4440

FDA Clears First Laser for Treating Tooth Decay
The Food and Drug Administration has cleared for marketing the first laser system for treating tooth decay.

The erbium YAG laser system, made by Premier Laser Systems of Irvine, Calif., was cleared for use directly on teeth. Lasers previously have been cleared only for dental use on soft tissue such as the gums.

"Use of lasers in dentistry is medicine for the 21st Century. They will give dentists and patients a significant new option for treating decay and doing other related procedures," said Bruce Burlington, M.D., director of FDA's Center for Devices and Radiological Health.

Studies conducted by the manufacturer showed that the laser is as safe and effective as a high speed drill for removing dental decay and preparing a cavity for a filling. The laser is reported to be noisy, but the noise is different from that of a standard drill. The manufacturer's study indicated that fewer patients needed anesthetic for pain.

The laser also was cleared to roughen the enamel, a procedure used to improve bonding of the restoration.

The laser system consists of a box­like laser console and a fiber optic cable with a dental handpiece at the end. Visually, the laser handpiece resembles a standard high speed drill. And like dental drills, the laser uses water or air to cool the tooth and clean the surface during removal of decay and cavity treatment. Dentists and patients will be required to wear goggles during procedures to protect their eyes.

The manufacturer conducted two clinical studies in which the laser was used to treat teeth. In the first, over 500 teeth with decay were treated with the laser and later evaluated for damage to the tooth's nerve and blood supply. No adverse events were reported.

Some 125 patients with decay were enrolled in the second study. Half were treated with the laser; the other half were treated with a high speed drill. The laser was shown to be as safe and effective as the drill in removing decay and preparing the tooth for a filling.

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